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Comparison Of Early Mobilization And Electrical Stimulation On Functional Recovery After Lumbar Disc Herniation Surgery (EMES-LDH)

2026年6月12日 更新者:salih tan、Istanbul Medipol University Hospital

Comparison Of Early Mobilization And Electrical Stimulation-Supported Rehabilitation On Functional Recovery, Pain Level, And Mobility After Lumbar Disc Herniation Surgery: A Prospective Randomized Controlled Trial

This randomized controlled trial aims to compare the effectiveness of early mobilization alone versus early mobilization combined with electrical stimulation on functional recovery following lumbar disc herniation surgery. Lumbar disc herniation is a common cause of low back pain and functional limitation, significantly affecting quality of life.

Although surgical intervention is effective in patients who do not respond to conservative treatment, optimal postoperative recovery largely depends on appropriate rehabilitation strategies. Early mobilization is widely recommended to prevent complications, preserve muscle function, and facilitate return to daily activities. In addition, electrical stimulation modalities such as neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS) have been increasingly integrated into rehabilitation programs to enhance pain control, muscle activation, and neuromuscular re-education.

In this study, a total of 60 participants who have undergone primary lumbar disc herniation surgery will be randomly assigned into two groups. The first group will receive an early mobilization program alone, while the second group will receive early mobilization combined with electrical stimulation (NMES/TENS). The intervention period will last 6 to 8 weeks, with sessions conducted three times per week.

Primary outcomes include functional disability measured by the Oswestry Disability Index (ODI) and pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes include functional mobility assessed by the Timed Up and Go (TUG) test, walking speed assessed by the 10-Meter Walk Test (10MWT), and muscle strength evaluated using manual muscle testing (MMT).

The findings of this study are expected to contribute to the development of evidence-based postoperative rehabilitation protocols and to clarify the clinical effectiveness of electrical stimulation in patients undergoing lumbar disc herniation surgery

研究概览

详细说明

Lumbar disc herniation is one of the most prevalent musculoskeletal conditions leading to low back pain, disability, and reduced functional capacity in adults. Surgical treatment is commonly indicated in patients with persistent symptoms or neurological deficits who do not respond to conservative management. Despite successful surgical intervention, postoperative recovery outcomes vary considerably and are highly influenced by rehabilitation strategies.

Early mobilization is considered a cornerstone of postoperative rehabilitation, as it reduces the risk of complications such as deep vein thrombosis, muscle atrophy, and joint stiffness. It also promotes faster recovery of functional independence and return to daily activities. However, early mobilization alone may not be sufficient to optimize neuromuscular recovery and pain management in all patients.

Electrical stimulation modalities, including neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS), have been increasingly utilized in rehabilitation settings. NMES facilitates muscle activation and prevents disuse atrophy, while TENS is widely used for pain modulation through neurophysiological mechanisms such as gate control theory. These modalities may provide additional benefits when combined with conventional rehabilitation approaches.

However, there is a limited number of high-quality randomized controlled trials directly comparing early mobilization alone with electrical stimulation-supported rehabilitation in patients following lumbar disc herniation surgery. This gap in the literature highlights the need for well-designed clinical trials to guide evidence-based practice.

Study Design

This study is designed as a prospective, two-arm, parallel-group randomized controlled trial. Participants will be randomly allocated using a computer-generated randomization method into one of two groups:

Group 1: Early mobilization program Group 2: Early mobilization combined with electrical stimulation (NMES/TENS) Intervention Protocol Both groups will participate in a structured rehabilitation program conducted three times per week for 6-8 weeks. The early mobilization program will include gradual ambulation, posture training, range of motion exercises, and functional activity training.

In the intervention group, electrical stimulation will be applied to paraspinal and lower extremity muscle groups. The parameters of NMES and TENS will be adjusted based on patient tolerance and clinical indications.

Outcome Measures Assessments will be performed at baseline (pre-intervention) and after completion of the intervention program.

Primary Outcomes:

Functional disability: Oswestry Disability Index (ODI) Pain intensity: Visual Analog Scale (VAS)

Secondary Outcomes:

Functional mobility: Timed Up and Go (TUG) test Walking speed: 10-Meter Walk Test (10MWT) Muscle strength: Manual Muscle Testing (MMT) Eligibility Criteria Participants aged between 18 and 65 years who have undergone primary lumbar disc herniation surgery and are in the early postoperative period (within the first 2 weeks) will be included. Patients with previous spinal surgery, severe neurological deficits, contraindications to electrical stimulation (e.g., pacemaker), or serious systemic diseases will be excluded.

Statistical Analysis Data will be analyzed using IBM SPSS Statistics software. Normality will be assessed using the Shapiro-Wilk test. Between-group comparisons will be performed using independent samples t-test or Mann-Whitney U test, while within-group comparisons will be analyzed using paired samples t-test or Wilcoxon signed-rank test. A two-way repeated measures ANOVA will be used to evaluate group-by-time interactions. A p-value of less than 0.05 will be considered statistically significant.

Expected Outcomes and Significance This study aims to provide high-quality evidence regarding the comparative effectiveness of early mobilization and electrical stimulation-supported rehabilitation. The results are expected to support clinical decision-making, optimize postoperative rehabilitation protocols, and contribute to the advancement of evidence-based physiotherapy practices.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age between 18 and 65 years
  • Patients who have undergone primary lumbar disc herniation surgery
  • Being in the early postoperative period (within the first 2 weeks after surgery)
  • Clinically stable condition
  • Ability to understand and follow instructions
  • Willingness to participate in the study and provide informed consent

Exclusion Criteria:

  • History of previous spinal surgery
  • Presence of severe neurological deficits (e.g., progressive motor loss, cauda equina syndrome)
  • Contraindications to electrical stimulation (e.g., pacemaker, implanted electronic devices)
  • Presence of severe systemic or uncontrolled chronic diseases (e.g., severe cardiovascular, respiratory, or metabolic disorders)
  • Cognitive impairment or inability to cooperate with rehabilitation program Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Early Mobilization + Electrical Stimulation
Participants in this group will receive the same early mobilization program combined with electrical stimulation (NMES and/or TENS). Electrical stimulation will be applied to paraspinal and lower extremity muscle groups based on patient tolerance and clinical indications. The rehabilitation program will be conducted three times per week for 6-8 weeks.
A structured early mobilization program initiated in the early postoperative period following lumbar disc herniation surgery. The program includes gradual ambulation, posture training, range of motion exercises, and functional activity training. Sessions will be conducted three times per week for 6-8 weeks. The program is designed to improve functional recovery, mobility, and independence in daily activities.
Electrical stimulation will be applied as an adjunct to early mobilization in the postoperative rehabilitation of lumbar disc herniation. Neuromuscular electrical stimulation (NMES) will be used to facilitate muscle activation and prevent muscle atrophy, while transcutaneous electrical nerve stimulation (TENS) will be used for pain modulation. Stimulation will be applied to paraspinal and lower extremity muscle groups according to patient tolerance and clinical indications. Sessions will be conducted three times per week for 6-8 weeks.
有源比较器:Early Mobilization
Participants in this group will receive a structured early mobilization program following lumbar disc herniation surgery. The program will include gradual ambulation, posture training, range of motion exercises, and functional activity training. Sessions will be conducted three times per week for 6-8 weeks. No electrical stimulation will be applied in this group
A structured early mobilization program initiated in the early postoperative period following lumbar disc herniation surgery. The program includes gradual ambulation, posture training, range of motion exercises, and functional activity training. Sessions will be conducted three times per week for 6-8 weeks. The program is designed to improve functional recovery, mobility, and independence in daily activities.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Oswestry Disability Index (ODI)
大体时间:Baseline (pre-intervention) and 8 weeks post-intervention
The Oswestry Disability Index (ODI) will be used to evaluate functional disability related to low back pain following lumbar disc herniation surgery. The questionnaire consists of 10 sections assessing activities of daily living including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, and traveling. Each section is scored from 0 to 5, and total scores are expressed as a percentage, with higher scores indicating greater disability.
Baseline (pre-intervention) and 8 weeks post-intervention
Visual Analog Scale (VAS) for Pain
大体时间:Baseline (pre-intervention) and 8 weeks post-intervention
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10 cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark their perceived pain level. The VAS is widely used for both acute and chronic pain assessment and is highly sensitive to clinical change.
Baseline (pre-intervention) and 8 weeks post-intervention

次要结果测量

结果测量
措施说明
大体时间
Timed Up and Go Test (TUG)
大体时间:Baseline and 8 weeks post-intervention
The Timed Up and Go (TUG) test will be used to assess functional mobility and balance. Participants will rise from a standard chair, walk 3 meters, turn, return, and sit down. The time in seconds will be recorded, with lower times indicating better functional mobility.
Baseline and 8 weeks post-intervention
10-Meter Walk Test (10MWT)
大体时间:Baseline and 8 weeks post-intervention
Walking speed will be evaluated using the 10-Meter Walk Test. Participants will walk a 10-meter distance at a comfortable pace, and time will be recorded. Walking speed (m/s) will be calculated, with higher values indicating better functional ambulation capacity.
Baseline and 8 weeks post-intervention
Manual Muscle Testing (MMT)
大体时间:Baseline and 8 weeks post-intervention
Muscle strength will be assessed using Manual Muscle Testing (MMT), graded on a 0-5 scale. A score of 0 indicates no muscle contraction, while 5 indicates normal muscle strength. Key muscle groups of the lower extremity and paraspinal region will be evaluated.
Baseline and 8 weeks post-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月30日

初级完成 (估计的)

2026年7月10日

研究完成 (估计的)

2026年7月30日

研究注册日期

首次提交

2026年5月3日

首先提交符合 QC 标准的

2026年5月3日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Individual participant data (IPD) sharing is currently not planned at the time of study registration. The data generated in this study are part of an academic thesis project and will primarily be used for scientific publication and dissertation purposes. Any potential future data sharing will depend on institutional policies, ethical committee regulations, and data protection requirements. If considered, de-identified aggregated datasets may be shared upon reasonable request after publication of the primary results, in accordance with applicable ethical and legal standards.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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